Diagnostic Products Corp Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Brand
Diagnostic Products Corp
Lot Codes / Batch Numbers
Lots 302 and 303
Products Sold
Lots 302 and 303
Diagnostic Products Corp is recalling Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303 due to Adverse trend in stability, controls biased or out of range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Adverse trend in stability, controls biased or out of range.
Recommended Action
Per FDA guidance
Recall was initiated by phone using a script, to be followed up with a letter and response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026